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Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy

K

Konya Meram State Hospital

Status

Completed

Conditions

Postoperative Recovery

Treatments

Other: local anesthetic injection
Other: Standard perioperative and postoperative analgesia protocol.

Study type

Interventional

Funder types

Other

Identifiers

NCT04112394
ESP-Quality of Recovery

Details and patient eligibility

About

The primary aim of this prospective, randomized study is to evaluate the effect of erector spinae block (ESP) on quality of recovery with the QoR-40 questionnaire in patients undergoing elective laparoscopic cholecystectomy.

Full description

Laparoscopic cholecystectomy, one of the most common general surgical procedures, is the gold standard for the treatment of symptomatic gallbladder diseases. Although it is considered as minimally invasive surgery, pain in the early postoperative period is still meaningful. Proper pain control is essential for optimizing clinical outcomes and earlier ambulation after surgery. Traditional pain management with opioids provide good pain control, however, have undesirable side effects such as nausea, vomiting, and respiratory depression. Multimodal analgesia strategies with different classes of analgesics or local anesthetics may enhance pain relief and reduce side effects after surgery. The ESP a newer regional nerve blockade, has been used as part of a multimodal strategy to optimize postoperative pain control. The primary aim of this study is to evaluate the effect of ESP block on postoperative recovery quality in patients undergoing laparoscopic cholecystectomy with QoR-40 recovery questionnaire. Secondary aim is to assess the effect of ESP block on postoperative pain, nausea, and vomiting.

Study hypothesize is that patients who receive an ESP block in addition to the current standard of care, consisting of parenteral opioids and paracetamol, will have a clinically significant improvement in their QoR-40 at postoperative day 1 and lower pain levels, as measured by NRS in comparison to those patients who receive the current standard of care along.

Enrollment

82 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiology (ASA) physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

  • a history of allergy to local anesthetics
  • known coagulation disorders
  • infection near the puncture site
  • Chronic opioid intake
  • Patient with psychiatric disorders
  • inability to communicate

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

ESP Group
Experimental group
Description:
In addition to routine standard perioperative and postoperative analgesia protocol patients will receive a single shot of local anesthetic injection at the erector spinae plane.
Treatment:
Other: local anesthetic injection
Control
Other group
Description:
Patients will receive standard perioperative and postoperative analgesia protocol.
Treatment:
Other: Standard perioperative and postoperative analgesia protocol.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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